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					A-0257
§482.25(b)(5) Drugs and biologicals not specifically prescribed as to time or number of doses
must automatically be stopped after a reasonable time that is predetermined by the medical
staff.
Interpretive Guidelines §482.25(b)(5)


In accordance with accepted standards of practice, the medical staff, in coordination and
consultation with the pharmacy service, determines and establishes the reasonable time to
automatically stop orders for drugs and biologicals not specifically prescr


Survey Procedures §482.25(b)(5)
Review policies and procedures to determine that there is a protocol established by the medical staff
to discontinue and review patients' medical records to determine compliance with stop-order policy.

A-0258
0482.25(b)(6) Drug administration errors, adverse drug reactions, and Incompatibilities must
be immediately reported to the attending physician and, if appropriate, to the hospital-wide
quality assurance program.
Interpretive Guidelines §482.25(b)(6)
Drug administration errors, adverse drug reactions, and drug incompatibility must be immediately
reported to the patient's attending physician, or when appropriate the covering physician. When the
covering physician is notified due to the attending
    Survey Procedures §482.24(c)(2)(viii)
    Select a sample of patients who have been discharged for more than 30 days.
    Request their medical records. Are those records complete? Does each record have
    the patient's final diagnosis?
    A-0247
    §482.25 Condition of Participation: Pharmaceutical Services
    The hospital must have pharmaceutical services that meet the needs of the
    patients.
    The institution must have a pharmacy directed by a registered pharmacist or a
    drug storage area under competent supervision. The medical staff is
    responsible for developing policies and procedures that minimize drug errors.
    This function may be delegated to the hospital's organized pharmaceutical
    service.
    Interpretive Guidelines §482.25

    Provision of pharmaceutical services must meet the needs of the patients' therapeutic
    goal by promoting a safe medication use process that ensures optimal selection of
    medications, dose, dosage form, frequency, route, duration of therapy and that
    substantially reduces or eliminates adverse drug events and duplication of treatment.
    The hospital's pharmacy must be directed by a registered pharmacist. If a drug storage
    area is used instead of a pharmacy at any location providing pharmacy services, that
    storage area must be under competent supervision in accordance with State and
    Federal law.
    Pharmaceutical Services would include:
    • The procuring, manufacturing, compounding, packaging, dispensing, ordering,
    distributing, disposition, use, and administering of all medications, biologicals,
    chemicals and the use of medication related devices.
    • Provision of medication-related information to hospital health care professionals
    and patients necessary to optimize therapeutic outcomes.
    • provision of pharmaceutical care. Pharmaceutical care is defined as the direct,
    responsible provision of medication-related care for the purpose of achieving definite
    • Determination of the presence of medication-therapy problems both potential and
    actual:
                  • Identification and specification of pharmacotherapeutic goals;
                 • Development of a pharmacotherapeutic regimen;
                 • Implementation of a monitoring plan in collaboration with the
                 patient, if
                 • Monitoring the effects of the pharmacotherapeutic regimen; and
                 applicable, and other health care professionals;
                   • Redesigning the regimen and monitoring plan as indicated.
    Medication errors are a substantial source of morbidity and mortality in the
    hospitalized setting. Therefore, the development of policies and procedures to
    minimize medication errors should be based on accepted professional principles;
    external alerts and proactive review of facility reported and reviewed adverse drug
    events. It is important to flag new types of mistakes and continually improve and
    refine things, based on what went wrong.
    The hospital's medical staff must develop policies and procedures to minimize drug
    errors, but may delegate this function to the hospital's organized pharmaceutical
    service.
    Policies and procedures to minimize drug errors should include:
                 • High-alert medications - dosing limits, administration guidelines,
                 packaging, labeling and storage;
                 • Limiting the variety of medication-related devices and equipment. For
                 Example limit the types of general-purpose infusion pumps to one or
                 two;
                 • Availability of up-to-date medication information;
                 • Availability of pharmacy expertise. Pharmacist available on-call when
                 pharmacy does not operate 24 hours communication practices to
                 • Standardization of prescribing and a day;
o                include:
A
                                    o All elements of the order – dose, strength, units
                                    (metric), route, frequency, and rate;
                                    o Alert systems for look-like and sound-alike drug
                                    names;
                                    o Use of facility approved pre-printed order sheets
          • That orders to "resumewhenever orders" are prohibited;
                                             possible.
                                  previous
          • A voluntary, non-punitive, reporting system to monitor and report adverse
           drug events (including medication errors and adverse drug reactions);
           • The preparation, distribution, administration and proper disposal of
           hazardous medications;
           • Drug recalls;
           • That patient-specific information is readily accessible to all individuals
           involved in provision of pharmaceutical care. The patient information must be
           sufficient to properly order, prepare, dispense, administer and monitor
           medications as appropriate;
           • Identification of when weight-based dosing for pediatric populations is
           required; and
           • Requirements for review and revision based on facility-generated reports of
           adverse drug events and QAPI activities.
    The hospital should have policies and procedures to actively identify potential and
    actual adverse drug events. Proactive identification could include; direct observation
    of medication administration, review of patient's clinical records, identification of
    patient signals that would warrant immediate review of patient's medication therapy
    and implementation of medication use evaluation studies.
    The hospital should have a means to incorporate external alerts and/or
    recommendations from national associations and governmental agencies for review
    and facility policy and procedure revision consideration. National associations could
    include Institute for Safe
    Medications Practice, National Coordination Council for Medication Error
    Reporting and
    Prevention and Joint Commission for Accreditation of Health Care Facilities,
    Sentinel
    Event Reports. Governmental agencies may include: Food and Drug Administration,
    Med Watch Program, and Agency for Health Care Research and Quality.
    The hospital's pharmacy services must be integrated into its hospital-wide QAPI
    program.
    •Interview the chief pharmacist or the individual delegated to fulfill the chief
    pharmacist's functions. Determine that either the medical staff has developed policies
    and procedures regarding the management of pharmaceuticals or that this function is
    fulfilled by the pharmacy service.
    •Verify that the purpose of pharmaceutical policies and procedures is to minimize
    drug errors. Review the pharmaceutical policies and procedures, the hospital's
    formulary and, if there is a pharmacy and therapeutic committee, the minutes of the
    committee meetings.
    •Does a multidisciplinary committee composed of representatives from nursing,
    pharmacy, administration and medicine develop policies and procedures?
    •Are there policies and procedures to minimize drug errors?
    •Are policies and procedures reviewed and amended based on:
                   o Facility-generated reports of adverse drug events;
                   o Facility QAPI activities pertaining to pharmaceutical care;
                   o Evaluation of external alerts and/or recommendations from national
                   associations;
                   o Evaluation of literature for new technologies or successful practices
                   that have demonstrated enhanced medication safety in other
    •Is the staff familiar with the medication-related policies and procedures?
    •Is there a method to periodically review and evaluate the actual implementation of
    pharmaceutical policies and procedures by staff?
    •Upon review of patient clinical record are issues with regard to provision of
    pharmaceutical services identified? Is the facility aware of the issues? Was there a
    failure to implement a policy and procedure?•
    •Are pharmacists an integral component of pharmaceutical care?
    •Verify that the hospital's pharmacy services is integrated into its hospital-wide QAPI
    program.
§482.25(a) Standard: Pharmacy Management and Administration
The pharmacy or drug storage area must be administered in accordance with
accepted professional principles.

Interpretive Guidelines §482.25(a)
The hospital may utilize a unit dose system, individual prescription, floor stock system or
a combination of these systems, properly stored.

Pharmaceutical services must be administered in accordance with accepted professional principles.
Accepted professional principles includes compliance with applicable Federal and State laws,
regulations, and guidelines governing pharmaceutical services, as well as, standards or
recommendations promoted by nationally recognized professional organizations. Agencies and
organizations could include FDA, NIH, American Society of Health-System Pharmacists, etc.
A fundamental purpose of pharmaceutical services is to ensure the safe and appropriate use of
medications and medication-related devices. The pharmacy director, with input from appropriate
hospital staff and committees, develops, implements and periodically reviews and revises policies and
procedures governing provision of pharmaceutical services.
Methods a hospital may use to maintain professional principles include:

• Policies and procedures have been developed and are being followed;
• Drugs and biologicals are stored in accordance with manufacturer's directions and State and Federal
requirements;
•Employees provide pharmaceutical services within their scope of license and education;
• Pharmacy records have sufficient detail to follow the flow of pharmaceuticals from their entry
into the hospital through ispensation/administration;
•Maintaining controls over drugs and medications including the floor stock and those of the
pharmacy or drug room;
• Maintaining pharmacy and accounting records pertaining to the requisitioning and dispensing
of drugs and pharmaceutical supplies
    • Ensuring that drugs are being dispensed only by a licensed pharmacist;
    • Only pharmacists or pharmacy-supervised personnel compound, label and dispense
    drugs or biologicals.
Survey Procedures §482.25(a)
• Are the policies and procedures consistent with accepted professional principles?
• Determine that professional principles are maintained by verifying that:
   o Policies and procedures have been developed and are being followed;
    o Drugs and biologicals are stored in accordance with manufacturers directions and State and Federal requirements;
    o Records have sufficient detail to follow the flow of control from entry through dispensation; and
    o Employees provide pharmaceutical services within their scope of license and education.
• Does the hospital have a means to incorporate external alerts and/or recommendations from national associations and governmental agencies for review and facility policy and procedure revision consideration?
• Are policies developed to promote consistent application of pharmaceutical services and care throughout the hospital?
• Is the pharmacy director periodically monitoring implementation of policies and procedures?
• Are policies and procedures reviewed and revised as warranted?
• Are services provided in a manner consistent with accepted professional principles?
• Is the pharmacy responsible for the procurement, distribution and control of all medication products used in the hospital (including medication-related devices) for inpatient and outpatient care?
A-0249
§482.25(a)(1) A full-time, part-time, or consulting pharmacist must be responsible for
developing, supervising, and coordinating all the activities of the pharmacy services.

Interpretive Guidelines §482.25(a)(1)
Direction of pharmaceutical services may not require continuous on-premise supervision at the
hospital's single pharmacy or at any pharmacy location but may be accomplished through regularly
scheduled visits, and/or telemedicine in accordance with Federal and
State law and regulation and accepted professional principles.
A single pharmacist must be responsible for the overall administration of the pharmacy service and
must be responsible for developing, supervising, and coordinating all the activities of the hospital
wide pharmacy service.
The job description or the written agreement for the responsibilities of the pharmacist should be
clearly defined and include development, supervision and coordination of all the activities of
pharmacy services.
A professional, competent, legally qualified pharmacist must manage the pharmacy. The Director
of pharmacy service must be thoroughly knowledgeable about hospital pharmacy practice and
management.
Pharmacists and pharmacy technicians must perform their duties within scope of their license and
education.
The Pharmacy Director should be actively involved in those committees responsible for establishing
medication-related policies and procedures.
Survey Procedures §482.25(a)(1)
• Determine whether the pharmacist is a full-time, or part-time employee or employed on a
consultative basis.
• Review the implementation of the chief pharmacist's responsibilities by:
   o Reviewing written status reports;
   o Reviewing minutes of meetings (if any) with facility staff regarding pharmaceutical
services;
   o Reviewing schedules, time logs, etc.;
   o Reviewing the job description or the written agreement to see that the responsibilities of the
pharmacist are clearly defined and include development supervision and coordination of all the
activities of pharmacy services;
    o Determining whether the Pharmacy Director routinely evaluates the performance and
competency of pharmacy personnel? Do performance
evaluations include high-risk activities such as the compounding of hazardous medications,
pharmacy-based prescriptive activities (e.g. aminoglycoside protocols) and pharmaceutical care for
high-risk patients (pediatric, ICU, geriatric etc)?
• Determine whether the pharmacy director is actively involved in those
committees responsible for establishing medication-related policies and
procedures?
A-0250
§482.25(a)(2) The pharmaceutical service must have an adequate number of personnel to
ensure quality pharmaceutical services, including emergency services.

Interpretive Guidelines §482.25(a)(2)
There must be sufficient personnel to respond to the pharmaceutical needs of the patient population
being served.

The pharmaceutical services staff must be sufficient in types, numbers, and training to provide
quality services, including 24 hour, 7-day emergency coverage, or there is an arrangement for
emergency services, as determined by the needs of the patients and as specified by the medical staff.

The number of pharmacists and/or the number of hours of services provided by pharmacists at the
hospital, or at each location of the hospital that provides pharmaceutical services, must meet and be
in accordance with the needs of its patients and accepted professional principles (as previously
defined), and reflect the scope and complexity of the hospital's pharmaceutical services.

There must be sufficient numbers and types of personnel to provide accurate and timely medication
delivery, ensure accurate and safe medication administration and to provide appropriate clinical
services as well as the participation in continuous quality improvement programs that meet the
needs of the patient population being served.
Survey Procedures §482.25(a)(2)
• Determine that the pharmaceutical services staff is sufficient in number and training to provide
quality services, including 24 hour, 7-day emergency coverage, or there is an arrangement for
emergency services, as determined by the needs of the patients and as specified by the medical staff.

  • Determine if there are sufficient personnel to provide accurate and timely medication delivery,
  ensure accurate and safe medication administration and to provide appropriate clinical services as
  well as the participation in continuous quality improvement programs that meet the needs of the
  patient population being served.
A-0251
§482.25(a)(3) Current and accurate records must be kept of the receipt and disposition of all
scheduled drugs.
Interpretive Guidelines §482.25(a)(3)
Components of a record system to maintain current and accurate records of the receipt and
disposition of scheduled drugs would include:
• Accountability procedures to ensure control of the distribution, use, and disposition of all
scheduled drugs.
• Records of the receipt and disposition of all scheduled drugs must be current and must be
accurate.
• Records trace the movement of scheduled drugs throughout the service.
• The pharmacist is responsible for determining that all drug records are in order and that an
account of all scheduled drugs is maintained and reconciled.
• The record system, delineated in policies and procedures, tracks movement of all scheduled drugs
from the point of entry into the hospital to the point of departure either through administration to the
patient, destruction or return to the manufacture. This system provides documentation on scheduled
drugs in a readily retrievable manner to facilitate reconciliation of the receipt and disposition of all
scheduled drugs.
• All drug records are in order and an account of all scheduled drugs is maintained and any
discrepancies in count are reconciled promptly.
• The hospital system is capable of readily identifying loss or diversion of all controlled substances
in such a manner as to minimize the time frame between the actual loss or diversion to the time of
detection and determination of the extent of loss or diversion?
• Facility policies and procedures should minimize scheduled drug diversion.
Survey Procedures §482.25(a)(3)
• Determine if there is a record system in place that provides information on controlled substances
in a readily retrievable manner.
• Review the records to determine that they trace the movement of scheduled drugs throughout
the service.
• Determine if there is a system, delineated in policies and procedures, that tracks movement of
all scheduled drugs from the point of entry into the hospital to the point of departure either
through administration to the patient, destruction or return to the manufacture. Determine if this
system provides documentation on scheduled drugs in a readily retrievable manner to facilitate
reconciliation of the receipt and disposition of all scheduled drugs.

• Determine if the pharmacist is responsible for determining that all drug records are in order
and that an account of all scheduled drugs is maintained and periodically reconciled.
• Is the hospital system capable of readily identifying loss or diversion of all controlled
substances in such a manner as to minimize the time frame between the actual losses or
diversion to the time of detection and determination of the extent of loss or diversion?
• Determine if facility policy and procedures minimize scheduled drug diversion.
A-0252
§482.25(b) Standard: Delivery of Services

Ill order to provide patient safety, drugs and biologicals must be controlled and distributed in
accordance with applicable standards of practice, consistent with Federal and State law.
Interpretive Guidelines §482.25(b)
Drugs and biologicals must be controlled and distributed in acordance with applicable Federal and
Statae laws and regulations, and in accordance with applicable standards of practice. Applicable
standards of practice include compliance with all Federal and State
laws, regulations, and guidelines, as well as, standards and recommendations promoted by
nationally recognized professional organizations, that apply to pharmaceutical care and the control
and distribution of drugs and biologicals.
The procedures established to prevent unauthorized usage and distribution must provide for an
accounting of the receipt and disposition of drugs subject to the Comprehensive Drug Abuse
Preventionand Control Acto of 1970.
The pharmacist, in consultation with appropriate hospital staff and committees, is to develop and
implement guidelines, protocols, policies and procedures for the provision of pharmaceutical
services that ensure patient safety through the appropriate control and distribution of medications,
medication-related devices and biologicals.
For high risk medications and high-risk patients (pediatric, geriatric or patients with renal or
hepatic impairment) there should be systems in place to minimize adverse drug events.
Such systems could include but not limited to; checklists, dose limits, pre-printed orders, special
packaging, special labeling, double-checks and written guidelines. "High risk medications" are
those medications involved in a high percentage of medication errors and/or sentinel events and
medications that carry a higher risk for abuse, errors, or other adverse outcomes. Lists of high-risk
or high-alert drugs are available from such organizations as the Institute for Safe Medication
Practices (ISMP) and the United States
Pharmcopoeia (USP). Examples of high-risk drugs may include investigational drugs, controlled
medications, medications not on the approved FDA list, medications with a narrow therapeutic
range, psychotherapeutic medications and look-alike/sound-alike medications and those new to the
market or new to the hospital.
All medication orders (except in emergency situations) should be reviewed for appropriateness by a
pharmacist before the first dose is dispensed.

Review of medication orders should include:
• Therapeutic appropriateness of a patient's medication regimen;
• Therapeutic duplication in the patient's medication regimen;
• Appropriateness of the drug, dose, frequency, route and method of administration;
• Real or potential medication-medication, medication-food, medication-laboratory test and
medication-disease interactions;
• Real or potential allergies or sensitivities;
•Variation from organizational criteria for use
• Other contraindications;
The effects of medication(s) on patients are monitored to assure medication therapy is appropriate
and minimizes the occurrence of adverse events. That monitoring process includes:
•Clinical and laboratory data to evaluate the efficacy of medication therapy to anticipate or evaluate
toxicity and adverse effects;

• Physical signs and clinical symptoms relevant to the patient's medication therapy;
•Assessing the patient's own perceptions about side effects, and, when appropriate, perceived
efficacy.
Sterile products should be prepared and labeled in a suitable environment by appropriately trained
and qualified personnel.
The pharmacy should participate in hospital decisions about emergency medication kits.
The supply and provision of emergency medications stored in the kits must be consistent with
standards of practice and appropriate for a specified age group or disease treatment as well as
consistent with applicable Federal and State laws.
The pharmacy should be involved in the evaluation, use and monitoring of drug delivery systems,
administration devices and automated drug-dispensing machines? The evaluation and monitoring
should include the potential for medication errors.
There must be a process to report serious adverse drug reactions to the FDA in accordance with the
MedWatch program?
There is a policy that addresses the use of medications brought into the hospital by patients or their
families.
There is a process and policy to ensure that investigational medications are safety controlled and
administered. Procedures for the use of investigational medications include the following: A written
process for reviewing, approving, supervising and monitoring investigational medications
specifying that when pharmacy services are provided, the pharmacy controls the storage,
dispensing, labeling, and distribution of the investigational medication.
Medications dispensed by the hospital are retrieved when recalled or discontinued by the
manufacturer or the Food and Drug Administration (FDA) for safety reasons.
The hospital pharmacy must ensure that medication orders are accurate and that medications are
administered as ordered. The pharmacy should have a system to reconcile medications that are not
administered, that remain in the patient's medication drawer, slot, etc., when the pharmacy
inventories patient medications or restocks patient medications. The pharmacy should determine the
reason the medications were not used.
For example, did the patient refuse the medication, was there a clinical or treatment reason the
medication was not used, or was the medication not used due to an error?
Survey Procedures §482.25(b)
• Are there limits on the number of possible concentrations for a medication, particularly high-alert drugs like
morphine and heparin?
•Is access to concentrated solutions (e.g. potassium chloride. sodium chloride solutions greater than
0.9%) restricted?
•Are questions regarding the order resolved with the prescriber and a written notation of these
discussions documented in the patient's medical record or pharmacy copy of the prescriber's order?

•Identify and assess the quality assurance procedures for the preparation of sterile products.
•Is appropriate monitoring of medication therapy being conducted?
•Is the pharmacy involved in the evaluation, use and monitoring of drug delivery systems,
administration devices and automated drug dispensing machines? The evaluation and monitoring
should include the potential for medication errors.

•Is there a process to report serious adverse drug reactions to the Federal MedWatch program?

Review the procedures established to prevent unauthorized usage and distribution.•
•These procedures must provide for an accounting of the receipt and disposition of drugs subject to
the Comprehensive Drug Abuse Prevention and Control Act of 1970.
•Are medication storage areas periodically inspected to make sure medications are properly stored?

•Does the hospital retrieve and remove medications available or patient use when the hospital has
been informed of a drug recall? Does the recall include notification of patients that have been
impacted and those that would order, dispense or administer the medication?
A-0253
§482.25(b)(1) All compounding, packaging, and dispensing of drugs and biologicals must be
under the supervision of a pharmacist and performed consistent with State and Federal laws.


Interpretive Guidelines §482.25(b)(1)

All compounding, packaging, and dispensing of drugs and biologicals must be conducted by a
registered pharmacist or under the supervision of a registered pharmacist and performed consistent
with State and Federal laws.

Medications must be prepared safely. Safe preparation procedures could include:

  • Only the pharmacy compounds or admixes all sterile medications, intravenous admixtures, or
  other drugs except in emergencies or when not feasible (for example, when the product's stability
  is short).
  • Whenever medications are prepared, staff uses safety materials and equipment while preparing
  hazardous medications.
  • Wherever medications are prepared, staff uses techniques to assure accuracy in medication
  preparation.
  • Whenever medications are prepared, staff uses appropriate techniques to avoid contamination
  during medication preparation, which include but are not limited to the following:

   o Using clean or sterile technique as appropriate;
    o Maintaining clean, uncluttered, and functionally separate areas for product preparation to
minimize the possibility of contamination;
    o Using a laminar airflow hood or other appropriate environment while preparing any
intravenous (IV) admixture in the pharmacy, any sterile product made from non-sterile
ingredients, or any sterile product that will not be used with 24 hours; and
    o Visually inspecting the integrity of the medications.
Medications should be dispensed in a manner that is safe and meets the needs of the patient:
• Quantities of medications are dispensed which minimize diversion and potential adverse events
while meeting the needs of the patient;
• Medications are dispensed in a timely manner. The hospital must have a system that ensures that
medication orders get to the pharmacy and medications get back to patients promptly.
• Whenever possible, medications are dispensed in the most ready to administer form available
from the manufacturer or, if feasible, in unit dose that have been repackaged by the pharmacy;

• The hospital consistently uses the same dose packaging system, or, if a different system is used,
provides education about the use of the dose packaging system; and
• All concerns, issues or questions are clarified with the individual prescriber before dispensing.

Survey Procedures §482.25(b)(1)
• Determine that only pharmacists or pharmacy supervised personnel compound, label and
dispense drugs or biologicals in accordance with State and Federal laws and regulations and as
accepted national principles by:
   o Reviewing policies and procedures;

   o Interviewing pharmacy and hospital staff to determine how drugs and biologicals are prepared
and dispensed;
   o Observing on site dispensing and compounding operations (if applicable);
   o Reviewing records of drugs and biologicals removed from the pharmacy by non-pharmacy
personnel; and
   o Inspecting drug storage areas.
A-0254
§482.25(b)(2) Drugs and biologicals must be kept in a locked storage area.

Interpretive Guidelines §482.25(b)(2)

All drugs and biologicals must be kept in a locked room or container. If the container is mobile or
readily portable, when not in use, it must be stored in a locked room, monitored location, or secured
location that will ensure the security of the drugs or biologicals.
All drugs and biologicals must be stored in a manner to prevent access by non-authorized
individuals.
Persons without legal access to drugs and biologicals cannot have unmonitored access to drugs or
biologicals.
Persons without legal access to drugs or biologicals cannot have keys to medication storage rooms,
carts, cabinets, or containers. Whenever persons without legal access to the drugs or biologicals
have unmonitored access to or could gain access to the drugs or biologicals stored in an area, the
hospital is not in compliance with the requirement to store all drugs and biologicals in a locked
storage area.

Nursing Medication Carts, Anesthesia Carts, and Other Medication Carts
When not in use, nursing medication carts, anesthesia carts, and other medication carts (hereafter
referred to as "carts") containing drugs or biologicals must be locked or stored in a locked storage
room. However, due to the mobility of carts, when not in use, locked carts that contain drugs or
biologicals must be stored in a locked room or secure location.
Ka cart containing drugs or biologicals is in use and unlocked, someone with legal access to the
drugs and biologicals in the cart must be close by and directly monitoring the cart. That person
could be a nurse, a physician, or other individual who in accordance with State and Federal law and
hospital policy has legal access to the drugs and biologicals in the cart. That person must monitor
the cart and be aware of other people's activities near the cart. He/she is responsible for the security
of the drugs and biologicals in the cart.
Survey Procedures §482.25(b)(2)
• Determine that there is a policy for the safeguarding, transferring and availability of keys to the
locked storage area.
• Determine by inspection whether all medications are stored in a manner that prevents
unauthorized access.
• Determine if the facility identifies what personnel may have access to
medications.
A-0255
§482.25(b)(3) Outdated, mislabeled, or otherwise unusable drugs and biologicals
must not be available for patient use.
Interpretive Guidelines §482.25(b)(3)
The hospital must have a pharmacy labeling, inspection, and inventory management system that
ensures that outdated, mislabeled, or otherwise unusable drugs and biologicals are not available for
patient use.
Survey Procedures §482.25(b)(3)
• Spot-check the labels of individual drug containers to verify that they conform to State laws,
and/or contain the following minimal information:
    o Each patient's individual drug container bears his/her full name, the prescriber's name, and
strength and quantity of the drug dispensed. Appropriate accessory and cautionary statements are
included as well as the expiration date.
     o Each floor stock container bears the name and strength of the drug, lot and control number
of equivalent, expiration date.
• If the unit dose system is utilized, verify that each single unit dose package bears name and
strength of the drug, lot and control number equivalent, and expiration date.
• Inspect patient-specific and floor stock medications to identify expired, mislabeled or unusable
medications.
A-0256

§482.25(b)(4) When a pharmacist is not available, drugs and biologicals must be removed
from the pharmacy or storage area only by personnel designated in the policies of the medical
staff and pharmaceutical service, in accordance with Federal and State law.

Interpretive Guidelines §482.25(b)(4)
Routine after-hours access to the pharmacy by non-pharmacists for access to medication should be
minimized and eliminated as much as possible. The use of well-designed night
cabinets, after-hours medication carts, and other methods may preclude the need for non-pharmacist
to enter the pharmacy. Policies and procedures should be consistent with Federal and State Law.
If an urgent or emergent patient need occurs, the hospital must be able to provide medications to the
patients in its facility.
The hospital must have a process for providing medications to meet patient needs when the
pharmacy is closed.
When non-pharmacist health care professionals are allowed by law and regulation to obtain
medications after the pharmacy is closed, the following safeguards are applied:
• Access is limited to a set of medications that has been approved by the hospital. These
medications can be stored in a night cabinet, automated storage and distribution device, or a limited
• Only trained, designated prescribers and nurses are permitted access to medications.
• Quality control procedures (such as an independent second check by another individual or a
secondary verification built into the system, such as bar coding) are in place to prevent medication
retrieval errors.
• The hospital arranges for a qualified pharmacist to be available either on-call or at another
location (for example, at another organization that has 24-hour pharmacy service) to answer
questions or provides medications beyond those accessible to non-pharmacy staff.
• This process is evaluated on an on-going basis to determine the medications accessed routinely
and the causes of accessing the pharmacy after hours.

• Changes are implemented as appropriate to reduce the amount of times non-pharmacist health
care professionals are obtaining medications after the pharmacy is closed.

Survey Procedures §482.25(b)(4)
• Determine through pharmacy records that when the parmacist is not available, drugs are removed
from the pharmcy (drug storage area) only by a designated individual (in accordance with State law
if applicable) and only in amounts sufficient for immediate therapeutic needs.
• Review policies and procedures to determine who is designated to remove drugs and biologicals
from the pharmacy or starage area and the amount a non-pharmacist may remove in the absence of
a pharmacist. The individual(s) designated should be identified by name and qualifications.

• Determine that a system is in place that accurately documents the removal of medications (type
and quantity) from either the pharmacy or the after hours supply.
• Determine that the pharmacist reviews all medication removal activity and correlates the removal
with current medication orders in the patient medication profile.
• Determine if the pharmacist routinely reviews the contents of the after-hours supply to determine
if it is adequate to meet the after-hours needs of the hospital.
A-0257
§482.25(b)(5) Drugs and biologicals not specifically prescribed as to time or number of doses
must automatically be stopped after a reasonable time that is predetermined by the medical
staff.
Interpretive Guidelines §482.25(b)(5)

In accordance with accepted standards of practice, the medical staff, in coordination and
consultation with the pharmacy service, determines and establishes the reasonable time to
automatically stop orders for drugs and biologicals not specifically prescribed as to time or number
of doses. The hospital must implement, monitor, and enforce this automatic stop system.

Survey Procedures §482.25(b)(5)
Review policies and procedures to determine that there is a protocol established by the medical staff
to discontinue and review patients' medical records to determine compliance with stop-order policy.
A-0258
0482.25(b)(6) Drug administration errors, adverse drug reactions, and
Incompatibilities must be immediately reported to the attending physician and, if
appropriate, to the hospital-wide quality assurance program.
Interpretive Guidelines §482.25(b)(6)
Drug administration errors, adverse drug reactions, and drug incompatibility must be
immediately reported to the patient's attending physician, or when appropriate the covering
physician. When the covering physician is notified due to the attending physician not being
available, the patient's attending physician must be notified as soon as he/she is available.
Additionally in accordance with the regulation and 482.21, the hospital must report drug
administrative errors, adverse drug reactions and drug incompatibilities to its hospital wide
QAPI program.
Reduction of medication errors and adverse reactions can be achieved by effective
reporting systems that proactively identify causative factors and are used to implement
corrective actions to reduce or prevent reoccurrences. To facilitate reporting, the facility
should adopt a medication error and adverse drug reaction (ADR) definition that is broad
enough in scope to capture "near misses" and suspected ADRs as well as actual medication
errors and ADRs.
An example is the use of the National Coordinating Council Medication Error Reporting
and Prevention definition of a medication error.
"Any preventable event that may cause or lead to inappropriate medication use or patient
harm while the medication is in the control of the health care professional, patient, or
consumer. Such events may be related to professional practice, health care products,
procedures, and systems, including prescribing; order communication; product labeling,
packaging, and nomenclature; compounding; dispensing; distribution; administration;
education; monitoring; and use."
When compared to the traditional definition of a medication error (right patient, right drug,
right route, right time, right dose) all errors secondary to any aspect of medication
utilization (including purchasing, ordering, dispensing, administrative, preparation,
compounding, etc.) would be reported versus only those that occurred in the administration
phase of medication utilization.

In addition to broad scope definitions, the facility must also proactively identify medication
errors and adverse drug reactions. Reliance solely on incident reporting fails to identify the
majority of adverse drug events. Proactive identification includes Observation of
medications passes, concurrent and retrospective review of patient's clinical records, ADR
surveillance team, implementation of medication usage evaluations for high-alert drugs and
identification of indicator drugs or "patient signals" that, when ordered, or noted
automatically generate a drug regimen review for a potential adverse drug event.

The facility must have a method by which to measure the effectiveness of their reporting
system so as to identify whether or not their system(s) is identifying as many medication
errors and adverse drug reactions that would be expected for the size and scope of services
provided by their hospital. Such methods could include use of established benchmarks or
studies on reporting rates published in peer-reviewed journals.
To improve incident reporting the facility should adopt a non-punitive system with the
focus on the system and not the involved health care professionals.
Survey Procedures §482.25(b)(6)
• Determine that the hospital has an effective procedure that ensures drug administration
errors, adverse drug reactions, and drug incompatibilities are immediately reported to the
attending physician.
• Review records of medication errors and adverse drug reactions to determine that they are
reported immediately in accordance with written procedures, and that medications
administered and/or drug reactions are promptly recorded in the patient's medical record.


• Is the facility's definition of an adverse drug reaction and medication error based on
established benchmarks or studies on report rates published in peer-review journals? Is it
identifying as many medication errors and adverse drug reactions as would be expected for
the size and scope of services provided by the hospital?
• If upon review of patient's clinical records. a suspected ADR or medication error is
identified, determine if it was reported immediately to the attending or on-call physician, in
accordance, with written procedures and that it was promptly recorded in the patient's
medical record.
• Review QAPI activities for medication errors and adverse reaction reports to determine
if upon analyses of the reports that potential corrective actions are identified and
implemented, if appropriate.
• Determine if the number of medication errors and adverse drug reactions reported is
consistent with the size and scope of services provided by the hospital.
• Interview facility staff (nursing, pharmacy and medicine) to ascertain awareness of the
facility's policy on reporting and documentation of medication errors and adverse drug
reactions
A-0259
§482.25(b)(7) Abuses and losses of controlled substances must be reported, in accordance with
applicable Federal and State laws, to the individual responsible for the pharmaceutical
service, and to the chief executive officer, as appropriate.
Survey Procedures §482.25(b)(7)
• Interview the pharmacists, or pharmacy employees to determine their understanding of the
controlled drug policies.
• Conduct a spot check of drug use and other inventory records to ensure that drugs are properly
accounted for.
• Review reports of pharmaceutical services to determine if there are reported problems with
controlled drugs and what actions have been taken to correct the situation.
• Interview the Pharmacy Director, pharmacist and pharmacy employees to determine their
understanding of the controlled drug policies. Is there a policy and procedure for handling
controlled drug discrepancies?
• Review reports of pharmaceutical services to determine if there are reported problems with
controlled drugs and what actions have been taken to correct the situation.
• Determine if controlled drug losses were reported to appropriate authorities in accordance with
State and Federal laws.
A-0260
§482.25(b)(8) Information relating to drug interactions and information of drug therapy, side
effects, toxicology, dosage, indications for use, and routes of administration must be available
to the professional staff.

Interpretive Guidelines §482.25(b)(8)

The facility has immediately available sufficient texts and other resources on drug therapy. The
pharmacist also should be readily available by telephone or other means to discuss drug therapy,
interactions, side effects, dosage etc., with practitioners to assist in drug selection and with nursing
personnel to assist in the identification of drug-induced problems.

Survey Procedures §482.25(b)(8)

    • Examine the sources of drug information available at the nursing station and/or drug storage
    area and determine if they are current.
    • Determine whether staff development programs on drug therapy are available to facility staff
    to cover such topics as new drugs added to the formulary, how to resolve drug therapy
    problems, and other general information as the need arises.
A-0261
§482.25(b)(9) A formulary system must be established by the medical staff to assure quality
pharmaceuticals at reasonable costs.
Interpretive Guidelines §482.25(b)(9)

The medical staff must establish a formulary system. The formulary lists medications for dispensing
or administration that the hospital maintains or that are readily available. In accordance with
accepted standards of practice, the medical staff, in consultation with the pharmacy service, should
develop written criteria for determining what medications are available for dispensing or
administration. At a minimum, the criteria include the indication for use, effectiveness, risks
(including propensity for medication errors, abuse potential, and sentinel events), and costs.

Processes and mechanisms should be established to monitor patient responses to a newly added
medication before the medication is made available for dispensing or administration within the
hospital.

Medications designated as available for dispensing or administration are reviewed periodically
based on emerging safety and efficacy information.
The hospital should have processes to approve and procure medications that are not on the hospital's
medication list.

The hospital should have processes to address medication shortages and outages, including the
following:
• Communicating with appropriate prescribers and staff;
• Developing approved substitution protocols;

• Educating appropriate LIPs, appropriate health care professionals, and staff about these protocols;
and
• Obtaining medications in the event of a disaster.
Survey Procedures §482.25(b)(9)
• Interview the pharmacist to determine that the medical staff has established a formulary that lists
drugs that actually are available in the hospital.

• Interview the Pharmacy Director to determine that there is a process for creation and periodic
review of a formulary system.
• Determine that the formulary lists drugs that are available.

				
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